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Risperidone Orally Disintegrating

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 2, 2010

Target and mechanism

ModalitySmall molecule

Also known as Risperidone Orally Disintegrating Tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Risperidone Orally Disintegrating · 2 trials · 1 indication

Phase 1 2
NCT01155921Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fasting ConditionsHealthy
COMPLETED36 Analytics
NCT01155934Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed ConditionsHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability based on Cmax and AUC parameters
1 Month
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Risperidone Orally DisintegratingEXPERIMENTALRisperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
Risperdal M-TABACTIVE_COMPARATOR(Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products

Interventions

NameTypeDescription
Risperidone Orally Disintegrating TabletsDRUGRisperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: Subjects were included in the study only if they met all of the following criteria: * Healthy non-smoking (for at least 3 months) adult male volunteers, 18-45 years of age; * Weighing at least 60 kg for males and within 15% of their ideal weights (Table of "Desirable Weights of...

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